Facility

AESTHETICS BIOMEDICAL INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012204368
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	7227 N 16th St Ste 160 Phoenix, AZ, US 85020
Registration status	Active · expires 2026
Parent company	Aesthetics Biomedical Inc. (owner-operator 10051282)
Brand names	Vivace Ultra RF Microneedling System; UltraVision RF Microneedling System

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (3)

Skin Resurfacing Rf Applicator
Product code OUH (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560
Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IITerminated2020-03-13
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

FDA inspections (2)

VAI2020-01-21
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-03-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Aesthetics Biomedical Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AESTHETICS BIOMEDICAL INC. (FEI 3012204368) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012204368-aesthetics-biomedical-inc/

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